Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
374 participants
INTERVENTIONAL
2016-09-30
2018-03-31
Brief Summary
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The study is prospectively randomized with an all-comer setup. The patients are randomly selected for one of the systems. The surgery is performed in the standard fashion and chest tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32 French drain is placed in every patient and pericardial and/or pleural drains are optional.
The postoperative course does not vary from the clinical standard and the chest tubes are removed according to institutional standard. The clinical data about fluid amount, time of removal, air leaks, tamponade are routinely collected in a digital patient documentation system.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pleural drainage system Medela
These patients receive the digital Medela system
Pleural drainage system
Pleural drainage system is connected to the chest tubes after surgery.
Pleural drainage system Ocean
These patients receive the analogue Maquet system
Pleural drainage system
Pleural drainage system is connected to the chest tubes after surgery.
Interventions
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Pleural drainage system
Pleural drainage system is connected to the chest tubes after surgery.
Eligibility Criteria
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Inclusion Criteria
* capability to give informed consent
18 Years
ALL
No
Sponsors
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Kerckhoff Klinik
OTHER
Responsible Party
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Locations
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Kerckhoff Klinik
Bad Nauheim, , Germany
Countries
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Other Identifiers
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Medela1
Identifier Type: -
Identifier Source: org_study_id
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